telix pharmaceuticals limited · asx small and mid-cap conference dr christian behrenbruch managing...
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Telix Pharmaceuticals LimitedASX Small and Mid-Cap Conference
Dr Christian Behrenbruch
Managing Director and CEO
10th September 2020
Disclaimer
The information contained in this presentation is not intended to be an offer for subscription, invitation or recommendation with respect to
shares of Telix Pharmaceuticals Limited (“Telix”) in any jurisdiction, including the United States. No representation or warranty, express or
implied, is made in relation to the accuracy or completeness of the information contained in this document or opinions expressed in the course
of this presentation. The information contained in this presentation is subject to change without notification.
This presentation may contain forward-looking statements which can be identified by the use of words such as “may”, “should”, “will”, “expect”,
“anticipate”, “believe”, “estimate”, “intend”, “scheduled” or “continue” or similar expressions. Any forward-looking statements contained in this
presentation are subject to significant risks, uncertainties, assumptions, contingencies and other factors (many of which are outside the control
of, and unknown to Telix, and its directors, officers, employees, agents or associates), which may cause the actual results or performance to be
materially different from any future result so performed, expressed or implied by such forward-looking statements.
There can be no assurance or guarantee that actual outcomes will not differ materially from these statements. The data and results pertaining
to clinical subjects used in this presentation are illustrative of medical conditions and outcomes associated with potential applications of Telix’s
product pipeline. Actual results from clinical trials may vary from those shown. None of the products or potential products described in this
presentation have received a marketing authorization in any jurisdiction.
Telix Pharmaceuticals Limited (ASX: TLX) 2
Company Snapshot
• Late-stage portfolio of Molecularly Targeted Radiation (MTR)
products :
✓ Prostate cancer, renal cancer, glioblastoma
✓ Significant total addressable market value of US$850M & US$4B for prostate
imaging and therapy, respectively
✓ Clinically active in 25 countries, global reach
• Accomplished major milestones on the path to commercialisation
of TLX591-CDx (prostate cancer imaging)
✓ European Marketing Authorization Application submitted (April)
✓ U.S. FDA NDA submission preparation in progress
✓ U.S. commercial distribution agreements with Cardinal Health and Pharmalogic
• Acquired a licensed production facility in Seneffe, Belgium
✓ Vertically integrated drug product manufacturing for the European market
• Strong financial position
✓ Runway until late 2021, to deliver first 2 commercial products (prostate and kidney cancer imaging)
3Telix Pharmaceuticals Limited (ASX: TLX)
What is MTR? Precise Radiation Delivery
1. Targeted radiation delivery 2. Systemic administration 3. Dual benefit: imaging and therapy
Radioactive
Isotope
(The “Payload”)
Antibody or small molecule
binds to a cancer cell
(The “Targeting Molecule”)
Telix is targeting agent agnostic
(antibody or small molecule)
Administered systemically and binds
to cancer cells, wherever they are,
including small metastases
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Prostate cancer
TLX591-CDx (1)
Renal cell carcinoma
TLX250-CDx (2)
Glioblastoma
TLX101 (3)
Notes: (1) Courtesy of Ammar Chaudhry MD, City of Hope, Duarte CA, USA
(2) Courtesy of Radboud University Medical Centre, Netherlands
(3) Courtesy of ZentralKlinik Bad Berka, Germany
Cancer-specific Positron Emission
Tomography (PET) images of prostate, renal
and brain (GBM) cancers for diagnosis,
staging and treatment response assessment
Telix Pharmaceuticals Limited (ASX: TLX)
‘See It. Treat It’
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See… Treat…
Low dose / diagnostic
radioisotope and a PET
scanner images the
presence of the cancer
target
High dose / therapeutic
radioisotope treats the patient
Dosing and treatment
response guided by imaging
Telix Pharmaceuticals Limited (ASX: TLX)
TLX591
Telix’s Clinical Pipeline in Prostate, Kidney, Brain Cancer
Phase I Phase II Phase III CommercialTargeting
Molecule
Cancer
Cell
Target
Radio-
isotope
Pro
sta
te 68GaPSMA (2)Small
molecule
177LuPSMAAntibodyTLX591 TherapyTLX591 (177Lu–rosopatamab)
ImagingTLX591-CDx (68Ga-PSMA-11)
Bra
in (
1)
124ILAT1 (4)Small
molecule
131ILAT1Small
molecule
TLX101-CDx (Research use only) Imaging
TherapyTLX101 (131I-IPA)
Kid
ney Antibody CA IX (3)
177LuCA IX TLX250 (177Lu–girentuximab) Therapy
TLX250-CDx (89Zr–girentuximab) Imaging89Zr
Antibody
Notes: (1) Glioblastoma multiforme (GBM)
(2) PSMA = Prostate-specific membrane antigen 1
(3) CA IX = Carbonic anhydrase IX
(4) LAT1 = Large amino acid transporter 1
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Shaded arrows indicate completion expectations in the next 12 months
Telix Pharmaceuticals Limited (ASX: TLX)
Activity Focus Areas: Transition to Commercial Stage
Telix Pharmaceuticals Limited (ASX: TLX) 7
Pipeline
R&D
Clinical
Trials
Commercialisation
of TLX591-CDx
(prostate imaging)
Key Accomplishments Year to Date
Telix Pharmaceuticals Limited (ASX: TLX) 8
EU MAA submitted
for TLX591-CDx
(prostate imaging),
NDA preparation
Phase III meeting
with the FDA,
finalisation of
protocol in progress
Seneffe (Belgium)
site acquisition
completed for EU
manufacturing
US/EU/AU recruitment,
indication expansion,
breakthrough
designation
Multiple
distribution
agreements,
US and EU
Key hires to build Telix’s
international bench strength,
including US-based CMO
Active R&D including
$500k IMCRC grant
for advanced
manufacturing
Financial Dashboard: 1H 2020
(Telix is December Year-End)
Telix Pharmaceuticals Limited (ASX: TLX) 9
H1 2020
Comprehensive Loss
$17.6m
H1 2019:
$10.4m
$2.1m
H1 2019:
$1.6m
H1 2020
Receipts
+70% +28% -33%
H1 2020
Program Costs
$5.6m
H2 2019:
$8.3m
H1 2020
Corporate / Employment Costs
Flat
~$2.5m / Qtr
Current Clinical Activity
Telix Pharmaceuticals Limited (ASX: TLX) 10
STARLITE
Development Stage Asset Indication Status
Phase III
(Therapy)TLX591
Metastatic castrate-resistant
prostate cancer (mCRPC)
Ph III IND preparation in progress
– Q4 2020 planned start
Phase II (x2)
(Therapy)TLX250
Metastatic clear cell renal cell
cancer (ccRCC)
IND(s) in final preparation,
manufacturing complete
Phase I/II
(Therapy)TLX101
Recurrent glioblastoma
multiform (GBM)Recruiting
Phase III
(Diagnostic Imaging)TLX250-CDx
Clear cell renal cell cancer
(ccRCC) / indeterminate massRecruiting
Phase I/II
(Diagnostic Imaging)TLX250-CDx
Clear cell renal cell cancer
(ccRCC) / indeterminate massRecruiting
Phase II (Registry)
(Diagnostic Imaging)TLX599-CDx
Prostate cancer
(registry study)
Recruitment planned to
commence Q4 2020
Phase I
(Biodistribution)TLX592 Prostate cancer
Recruitment planned to
commence Q4 2020
EU Marketing Authorisation Status (TLX591-CDx)
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Telix has submitted an EU marketing authorisation application
(MAA) for TLX591-CDx (prostate cancer imaging)
• Submitted in April 2020, mostly based on pre-COVID-19 effort
• Danish Medicines Agency (DKMA) agreed to serve as reference
competent authority (CA)
• 14 countries selected in the first cohort of approval countries,
includes EU5 (+UK)
• Submission complete, now in individual CA review
• Expect ‘consensus’ late-2020 / early 2021
• In discussions with several healthcare authorities for temporary
marketing authorisations
US NDA Submission Status (TLX591-CDx / illumet®)
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Telix is in the final stages of preparing a New Drug Application
(NDA) to the US FDA
• Will be submitted this quarter (Q3)
• Delays due to both COVID-19 and management decision to expand
the product label based on FDA consultation and new clinical data
• All clinical data sources, data quality control and statistical analysis
complete. Highly supportive of Telix’s submission package
• Currently completing final documentation checks, package QC and
preparing for e-publishing
• Close cooperation with US partners (Cardinal Health, Pharmalogic)
for market launch
• 30+ IND ‘Letters of Authorisation’ issued to Telix’s Drug Masterfile
(DMF) for TLX591-CDx in the H1 of 2020
Other TLX591-CDx Jurisdictions in Progress
Telix Pharmaceuticals Limited (ASX: TLX) 13
TGA submission preparation in progress, expected to be submitted in Q4
2020. MSAC(1) approval likely mid-2021
Routine provision of compassionate use access under HealthCanada
requests. Currently preparing submission package
Swissmedic application in progress. A strategic jurisdiction for many countries
that follow EU/Swiss regulatory approvals
Favourable PMDA(2) and MHLW(3) consultations for establishing ‘bridging’
clinical activity in Japan to global marketing authorisation packages
Notes: (1) Medical Services Advisory Committee
(2) Pharmaceutical and Medical Device Agency
(3) Ministry of Health, Labour and Welfare
Four Main Indications for TLX591-CDx
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1. Primary staging in newly diagnosed high-risk prostate cancer
2. Biochemical recurrence (BCR) following prostatectomy or radiation therapy
3. Patient selection for PSMA targeted radio-ligand therapy (RLT)
4. Monitoring of response to systemic therapy
US$850M total addressable market opportunity
Unique product, optimized for the nuclear pharmacy
PSMA Imaging is a New Standard of Care for Prostate Imaging
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Notes: (1) Hofman M, et al. The Lancet 2020 (published online March 22, 2020).
(2) Trabulsi E, et al. Journal of Clinical Oncology 2020 (published online January 15, 2020).
RECOMMENDATIONS One or more of these imaging modalities should be used
for patients with advanced prostate cancer: conventional imaging (defined as
computed tomography [CT], bone scan, and/or prostate magnetic resonance imaging
[MRI] and/or next-generation imaging (NGI), positron emission tomography [PET],
PET/CT, or whole-body MRI) according to the clinical scenario.
Level 1 Evidence Clinical Practice Guidelines
Telix Pharmaceuticals Limited (ASX: TLX)
ProstACT: Phase III Prostate Cancer Therapy
Telix Pharmaceuticals Limited (ASX: TLX) 16
Valuable pre-Phase III meeting with the FDA completed (Q3)
• Currently refining the clinical protocol based on FDA feedback
• Very useful / positive feedback with respect to the use of imaging
(TLX591-CDx) for patient selection and enrichment
• Expect to send a further package to the FDA in the next 3-4 weeks
for an additional pre-IND meeting
• Phase III design has been further refined:
✓Well defined patient population
✓Clear proposed end-points
✓Considerably streamlined patient sample size
• Final protocol expected to be completed in mid-Q4
• Australian arm of ProstACT expect to commence end-2020 with US
patients in Q1 2021 (subject to FDA/TGA approval)
NDA submission to US FDA
Launch of ProstACT
Phase III trial
Five Events will Define the Next Six Months
17Telix Pharmaceuticals Limited (ASX: TLX)
Prostate program
Kidney program
Glioblastoma program
Market launch
readiness
First data out from
IPAX-1 trial
Completion of ZIRCON Phase
III trial
TLX591-CDx
TLX101
TLX591-CDx
TLX591TLX250-CDx
Summary
Telix Pharmaceuticals Limited (ASX: TLX) 18
Despite COVID-19, H1 was highly active with significant
commercial and program-related progress
• Effective management of Telix’s financial resources despite major
operational and clinical impact of COVID-19
• EU MAA submitted on time, US NDA delayed but on track for Q3
submission, other commercially useful jurisdictions in progress
• High level of commercial activity, including building global
distribution networks for TLX591-CDx and preparation for market
launch activities
• Global sales continuing to grow for TLX591-CDx
• H2 2020 will be extremely active for the company on both
commercial and clinical fronts
telixpharma.com
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